CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
Civco Belly Board MRI, Reusable non-sterile glass fiber recalled
Civco Medical Instruments is recalling Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, distributed nationwide in the US. The recall was initiated on 25 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0803-2014
- FDA event ID
- 66591
- Recalling firm
- Civco Medical Instruments, Kalona, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Oct 2013
- FDA classified
- 21 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 25 Oct 2013 | Recall initiated by company | |
| 21 Jan 2014 | Classified by FDA | +88 days |
| 29 Jan 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Where it was distributed
Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisKansasMassachusettsMarylandMichiganMinnesotaMontanaNorth CarolinaNew JerseyNew YorkOhioOklahoma
Questions about this recall
Is Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion recalled?
Yes. Civco Medical Instruments recalled Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion on 25 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0803-2014.
Why was it recalled?
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Which lots are affected?
Lot#'s: M551490 and M550150
Where was it sold?
Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS II | CollectEVAC, Sterile device with tubing and adaptor recalled | Civco Medical Instruments | Sterility | Nationwide |
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